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Summary: Manager, Drug Product (DP) Operations –is responsible for the planning, directing, and coordinating of the activities related to the Drug Product manufacturing processes for FDBT while maintaining a highly effective operation leading to the production of safe, efficacious and compliant therapeutics. The Manager of Drug Product Operations will oversee the cGMP production and equipment used for DP manufacture and viral bank filling for viral vector/gene therapy products in FDBT’s state of the art Flexible Manufacturing Facility.
Summary: The Quality Assurance (QA) Analyst III, under minimal direction, will be responsible for providing QA oversight of cGMP activities for manufacture of monoclonal antibodies, vaccines and gene therapies for early and late stage development and commercial manufacturing, with a focus on supporting qualification\validation of equipment, software and facilities.